Vascular closure system

ABSTRACT

A system for closing an opening in tissue may include an end effector that holds a staple, where the staple is plastically deformed to a splayed configuration for engaging tissue, then plastically deformed to a closed condition for closing the opening. The system may include one or more butterfly members configured to register the opening to the end effector.

FIELD OF THE INVENTION

The present invention relates generally to a system for closing anopening in a hollow tissue structure such as the femoral artery.

BACKGROUND

Millions of people each year undergo catheterization for reasonsincluding stent placement, angioplasty, angiography, atrial ablation,placement of abdominal aortic aneurysm grafts and/or stents, and otherinterventional cardiologic and vascular procedures. In a femoral arterycatheterization, an opening is made in the wall of the femoral artery,and a sheath is placed in that opening through which a guidewire and oneor more tools may be inserted for performing treatment on the patient.

After the sheath is removed, the opening in the femoral artery must beclosed. Compression is typically used to do so. Anticoagulation therapyis stopped, and manual pressure is applied to the site for up to an houruntil clotting seals the access site. The patient then must remainmotionless for up to 24 hours, generally with a sandbag or other heavyweight on the site to continue the compression. Many patients find thisprocedure, and the resultant bruising and pain, to be more unpleasantthan the actual interventional procedure that was performed.

Several types of closure devices and techniques have been developed inan attempt to facilitate closure of the opening in the femoral artery.However, acceptance of these devices and techniques has been limited forseveral reasons, including complexity of use, complication rates similarto traditional closure, and cost. One type of device utilizes suture toclose the opening. However, such devices are typically complexmechanically and consequently are complex to operate. Further, suchdevices often require an auxiliary knot-pushing tool to be used, furtherincreasing complexity. Other devices are ring-shaped or shaped in aconvoluted or tortuous manner, and are complicated and expensive tomanufacture. Another closure technique involves inserting a plug orslurry of collagen or other chemical composition into the opening and/orthe pathway in the leg between the opening and the skin. However,compression and lengthy bed rest are generally still required withchemical closure techniques, just as with traditional closure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a vascular closure system that includes anend effector, a shaft and a handle.

FIG. 2 is a perspective view of the end effector having butterflymembers in a first, collapsed configuration.

FIG. 3 a is a cross-section view of a butterfly member of the endeffector along the line A-A in FIG. 2.

FIG. 3 b is a cross-section view of a butterfly member of the endeffector along the line B-B in FIG. 2.

FIG. 4 is a perspective cross-section view of the end effector in afirst configuration.

FIG. 5 is a side view of the staple of FIG. 4 in a first configuration.

FIG. 6 is a side view of paddles and a finger that are utilized withinthe end effector.

FIG. 7 is a schematic view of tissue having a catheterization sheathpositioned therein.

FIG. 8 is a perspective view of the end effector having butterflymembers in a second, expanded configuration.

FIG. 8A is a schematic view of the handle and shaft of the vascularclosure system and their relationship with a sheath.

FIG. 9 is a perspective view of the end effector after the butterflymembers have been moved proximally.

FIG. 10 is a perspective cutaway view of the end effector in a secondconfiguration, as the staple is splayed.

FIG. 10A is a perspective view of the end effector in a thirdconfiguration, after the splayed staple has been shuttled distally.

FIG. 11 is a perspective view of the end effector in a fourthconfiguration, as the staple is closed.

FIG. 12 is a top view of an embodiment of a staple.

FIG. 13A is a side view of the distal end of one exemplary butterflymember.

FIG. 13B is a side view of the distal end of a different exemplarybutterfly member.

FIG. 14 is a side view of a first step in the operation of the closuresystem.

FIG. 15 is a side view of a second step in the operation of the closuresystem.

FIG. 16 is a side view of a third step in the operation of the closuresystem.

FIG. 17 is a side view of a fourth step in the operation of the closuresystem.

FIG. 18 is a side view of a fifth step in the operation of the closuresystem.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

Closure System

Referring to FIG. 1, a closure system 2 includes an end effector 4connected to a shaft 6, which in turn is connected to a handle 8. Theend effector 4 may be one or more separate components that are connectedto the shaft 6, or may be fabricated integrally with the distal end ofthe shaft 6. Referring also to FIG. 7, the end effector 4 is sized topass through a standard sheath 48 placed in a passage 53 in tissue 52for a standard catheterization procedure.

Referring also to FIG. 2, the end effector 4 includes at least onebutterfly member 10. Each butterfly member 10 acts to register tissuesuch as the wall of a blood vessel to the end effector 4, as describedin greater detail below. At least one butterfly member 10 may extendsubstantially distally from a housing 22 or other component of the endeffector 4. Alternately, at least one butterfly member 10 extends atleast partially in a different direction. Each butterfly member 10 maybe configured in any manner that allows it to move from a first,collapsed configuration to a second, expanded configuration, and back tothe collapsed configuration. As one example, at least one butterflymember 10 includes a first element 12, and a second element 14 connectedto the distal end of the first element 12. The first element 12 is notsubstantially deformable, and at least part of the second element 14 isdeformable to an expanded configuration. Alternately, either or both ofthe elements 12, 14 is deformable to an expanded configuration. Theelements 12, 14 may be shaped and configured in any suitable manner. Asone example, referring also to FIGS. 3 a-3 b, the first element 12 mayhave a semicircular cross-section or other curved cross-section along atleast part of its length. Such a cross section increases the moment ofinertia of the first element 12 and thereby increases its stiffness. Atleast part of the first element 12 may be partially tubular, hollow, orotherwise include an area configured to receive a portion of the secondelement 14, or vice versa. At least part of the first element 12 may besubstantially coaxial with the second element 14. The distal end 16 ofat least one butterfly member 10 may be blunt in order to prevent orminimize any disturbance to the tissue structure into which thebutterfly member 10 is inserted. For example, the distal end of at leastone butterfly member 10 may be curved at the junction between theelements 12, 14. At least one butterfly member 10 may have alongitudinal axis in the collapsed configuration that is offset from andsubstantially parallel to the longitudinal axis of the end effector 4and/or the shaft 6. The use of the term “axis” in this document is notlimited to use with respect to structures that are cylindrical orradially symmetrical, and the use of the term “axis” in conjunction witha structure does not and cannot limit the shape of that structure.Alternately, at least one butterfly member 10 is oriented differentlyrelative to the longitudinal axis of the end effector 4 and/or the shaft6.

The second element 14 may include two substantially planar segments 18longitudinally spaced from one another and connected to one another by ahinge element 20 between them, such that one segment 18 is positioneddistal to the other segment. The hinge element 20 may be a living hinge,such as a narrower area between the two segments 18 that bends to allowmovement between the segments 18. Alternately, the hinge element 20 maybe any structure or mechanism that allows for relative movement betweenthe segments 18. At least one of the segments 18 may be curved orotherwise non-planar. One of the planar segments 18 may extend to alocation at or in proximity to the distal end 16 of the correspondingbutterfly member 10. The segments 18 may be angled relative to oneanother when the butterfly member 10 is in the first, collapsedconfiguration. For example, the most-distal segment 18 may be angledrelative to the longitudinal axis of the corresponding butterfly member10 such that the distal end of that segment 18 is closer to thatlongitudinal axis than the proximal end of that segment 18, and themost-proximal segment 18 may be angled relative to the longitudinal axisof the corresponding butterfly member 10 such that the proximal end ofthat segment 18 is closer to that longitudinal axis than the distal endof that segment 18. Alternately, the segments 18 may be angleddifferently relative to one another. The angle between the segments 18allows the hinge 20 to deform or otherwise move upon application offorce to the second element 14, as described in greater detail below.The segments 18 may be angled relative to one another a greater amountwhen the butterfly member 10 is in the second, expanded configurationthan in the first, collapsed configuration. Alternately, the segments 18may be substantially parallel to one another and/or lie in substantiallythe same plane as one another. Referring to FIG. 13A, the segments 18each may be substantially the same length, such that they form asymmetrical shape upon actuation of the butterfly member 10.Alternately, referring to FIG. 13B, the segments 18 may differ inlength, such that they form a non-symmetrical shape upon actuation ofthe butterfly member 10.

Referring also to FIG. 2, the first element 12 may extend into thehousing 22 of the end effector 4 through a notch, aperture or otheropening. The first element 12 may instead extend along a groove or otherreceiving area of the housing 22, rather than or in addition toextending into the housing 22. The first element 12 is movable relativeto the housing 22. Alternately, the first element 12 is fixedsubstantially to the housing 22. The first element 12 may extend throughthe shaft 6 to the handle 8. The proximal end of the first element 12extends substantially proximally from the housing 22 in any suitableamount.

A proximal portion of the second element 14 may extend into a centerarea 26 of a proximal portion of the first element 12. That center area26 of the first element 12 may be referred to as the lumen of the firstelement 12 for convenience, even though the first element 12 may be openalong part of its perimeter, or may have a cross-section other thancircular, at any portion of its length. The longitudinal axis of thelumen 26 may be substantially coincident with the longitudinal axis ofthe first element 12, or may be offset from or otherwise alignedrelative to the longitudinal axis of the first element 12. The secondelement 14 may be movable relative to that lumen 26, such as by slidingsubstantially along or substantially parallel to the longitudinal axisof the lumen 26. Alternately, the second element 14 does not extend intothe lumen 26 of the first element 12. Alternately, the second element 14does not include a lumen 26. For example, both the first element 12 andthe second element 14 may be substantially flat, or gently curved. Theelements 12, 14 may be adjacent to one another, or spaced apart from oneanother, along at least part of their length, particularly where neitherelement 12, 14 includes a lumen 26. At least one of the elements 12, 14may be configured to move, such as by sliding, relative to at least partof the other element 12, 14. Alternately, at least part of the secondelement 14 includes a lumen 26 therein, and a portion of the firstelement 12 may extend into that lumen 26.

The first element 12 and the second element 14 may both be parts of anintegral whole, shaped to constitute the butterfly member 10. Forexample, the butterfly member 10 may be stamped from a sheet of metal,such as stainless steel. The butterfly member 10 may then be folded,where the first element 12 is on one side of the fold and the secondelement 14 is on the other side of the fold. At least a portion of eachmember 12, 14 may be folded into a semicircular or other shape as viewedlongitudinally, before or after the folding. Each butterfly member 10may be fabricated from any suitable material. As one example, at leastone butterfly member 10 may be fabricated from any material, such asnickel-titanium alloy, that is elastically or superelasticallydeformable between the first configuration and the second configuration.As another example, at least one butterfly member 10 may be fabricatedfrom any material, such as stainless steel or plastic, that isplastically deformable between the first configuration and the secondconfiguration. At least part of at least one butterfly member 10 may beplastically deformable between the collapsed configuration and theexpanded configuration. At least part of the butterfly member 10 may beannealed, such that it can be plastically deformed without fracturing.Both of the elements 12, 14 may be substantially rigid, such that theyare capable of transmitting both compressive and tensile force.

Referring also to FIG. 4, a staple 24 is initially positioned within aspace inside the end effector 4. Alternately, the staple 24 ispositioned differently within the end effector 4, or is positioned atthe end of the end effector 4 rather than within it. The staple 24 maybe sized and shaped in any suitable manner. As one example, referringalso to FIG. 5, the staple 24 may have a curved M-shape. However, thestaple 24 may have any other suitable shape. The staple 24 may have twotines 26, each extending at least partially in the distal direction. Thetines 26 may be curved, and may each have a shape and radius ofcurvature such that the tines 26 are generally not parallel to oneanother. The radius of curvature may be substantially coincident withthe path of travel of the tines 26 during closure of the staple 24. Thestaple 24 may be substantially bilaterally symmetrical, although it maybe asymmetrical if desired. The staple 24 may be a substantiallycontinuous solid. As used in this document, the term “solid” means thata structure has no slots, holes, apertures or other enclosed or boundedopenings defined therein.

The distal end of each tine 26 may have a substantially pointed orsharpened distal end. However, the distal ends of the tines 26 need notbe pointed or sharpened, particularly if the cross-sectional area ofeach tine 26 is small. Advantageously, each tine 26 has a single distalend that is not bifurcated or otherwise forked or split. The body of thestaple 24 extends proximally from the distal end of one tine 26 andcurves or angles toward the longitudinal centerline of the staple 24.This curve may extend outward from the longitudinal centerline of thestaple 24, then toward the longitudinal centerline of the staple 24.Alternately, the tine 26 may curve differently. The body of the staple24 reaches a peak 28, then extends distally and toward the longitudinalcenterline of the staple 24. The body of the staple 24 then reaches atrough 30, then extends proximally and away from the longitudinalcenterline of the staple to a second peak 28. The body of the staple 24continues distally to form the second tine 26, and ends at the distalend of the second tine 26. Alternately, the staple 24 may be shapeddifferently. For example, the staple 24 may have more than two tines 26.A valley 29 is the area on the staple 24 on the other side of the staple24 from a peak 28. For example, where a peak 28 of the staple 24includes a convex curve oriented proximally, the corresponding valley 29is a concave curve opening distally. Advantageously, the staple 24 issubstantially solid.

The staple 24 may include at least one tab 32 extending therefrom in anysuitable direction, such as substantially perpendicular to the body ofthe staple 24. Advantageously, the tab 32 extends from the trough 30 ofthe staple 24 or from a location in proximity to the trough 30. Thestaple 24 may include any suitable number of tabs 32. Each tab 32 issized and positioned to engage a correspondingsubstantially-longitudinal groove (not shown) in the housing 22. Thus,the tab 32 registers the staple 24 to the housing 22. Alternately,instead of or in addition to a tab 32, the staple 24 may include atleast one slot (not shown) that is sized and positioned to engage acorresponding substantially-longitudinal rib (not shown) defined on thehousing 22. Alternately, any other structure or mechanism may be used toregister the staple 24 to the housing 22.

The staple 24 may lie substantially in a single plane. That is, thestaple 24 is shaped such that a single plane extends through andsubstantially bisects the entire staple 24. Alternately, the staple 24does not lie substantially in a single plane. The longitudinal andlateral dimensions of the staple 24 overall may both be substantiallylarger than the height of the staple 24. Alternately, the staple 24 maybe sized differently. Referring also to FIG. 12, the proximal surface 62of the staple 24 optionally may be curved relative to a planeperpendicular to the longitudinal axis of the staple 24. For example,the proximal surface 62 of the staple 24 may take the shape of a twistedplane. The proximal surface 62 of the staple 24 may be twisted such thata line perpendicular to that proximal surface 62 on one side of thelongitudinal centerline of the staple 24 is skewed relative to a lineperpendicular to that proximal surface 62 on the other side of thelongitudinal centerline of the staple 24, and both such lines are skewedrelative to the longitudinal centerline of the staple 24.

The staple 24 may be plastically deformable. If so, the staple 24 may befabricated from stainless steel, titanium or any other suitableplastically-deformable material. Alternately, the staple 24 may beelastically deformable. If so, the staple 24 may be fabricated fromnickel-titanium alloy or any other suitable elastic or superelasticmaterial. The staple 24 may be fabricated from a single wire or otherpiece of material, having a rectangular, circular or othercross-section. The cross-section of the staple 24 may be substantiallyconstant along the entire staple 24, or may vary at different locationsalong the staple 24. For example, the cross-sectional area of the staple24 at certain locations may be less than at other locations, in order topromote bending in those locations having a lesser cross-sectional area.

Referring also to FIG. 10, a driver 34 is located proximally to thestaple 24, and is movable relative to the staple 24 such as by sliding.At least a portion of the driver 34 may be positioned within the housing22. The housing 22 may be at least partially hollow in order toaccommodate the driver 34. Advantageously, the housing 22 includes apassage 36 therein along which at least part of the driver 34 may slideor otherwise move. At least part of the passage 36 may guide the driver34 during at least part of its motion. The driver 34 may be configuredin any suitable manner. As one example, the driver 34 is an elongatedmember having a bifurcated distal end, where each bifurcation isconfigured to engage a corresponding peak 28 of the staple 24.Alternately, the distal end of the driver 34 is shaped differently. Thedriver 34 may be substantially flat, and may have a thicknesssubstantially equal to that of the staple 24. Alternately, the driver 34is shaped and/or configured differently, in any suitable manner.Optionally, the staple 24 may be fabricated integrally with the driver34. If so, the staple 24 is frangible from the driver 34, such that thestaple 24 separates from the driver 34 at a suitable time during orafter deployment. Fabrication of the staple 24 integrally with thedriver 34 may facilitate manufacturing.

Referring to FIGS. 4 and 6, a paddle assembly 38 may be located at leastpartially within the passage 36, at or near the distal end thereof. Thepaddle assembly 38 may include one or more paddles 40 and/or one or morefingers 42. As one example, two paddles 40 are utilized, and a finger 42is positioned between the paddles 40, where the paddles 40 and thefinger 42 are cantilevered from a base 44 of the paddle assembly 38. Atleast one paddle 40 may include a ridge 41 raised relative to aremainder of the paddle 40. The ridge 41 may be substantially linear,and may be substantially perpendicular to the longitudinal axis of thepaddle 40. The ridge 41 may be shaped as a ramp, with greater thicknessat its proximal edge than at its distal edge. The surface of the rampmay be straight, curved or complex. Alternately, the ridge 41 may be abump, shaped such as a section of a cylinder. Alternately, the ridge 41may be shaped and/or oriented in any other suitable manner. At least onepaddle 40 may include a post 43 at or near its distal end. Each post 43may be substantially cylindrical. Each post 43 extends from a remainderof the paddle 40, and may be oriented substantially perpendicular to thelongitudinal axis of the paddle 40. The finger 42 may be substantiallylinear, and extend substantially along a plane defined by the base 44 ofthe paddle assembly 38. The distal end of the finger 42 may extendsubstantially as far distally as the distal ends of the paddles 40, ormay extend distally any other suitable distance. A projection 46 extendsfrom a location at or near the distal end of the finger 42 substantiallyperpendicular to the longitudinal axis of the finger 42. Alternately,the projection 46 extends in a different direction. When the endeffector 4 is in an initial position, the distal end of the driver 34may be in contact with, or in proximity to, the base 44 of the paddleassembly 38. The projection 46 may include a concave depression or othersurface configured to slide along a post 45 extending from the housing22. The post 45 may guide and/or stabilize the projection 46.

Alternately, the paddle or paddles 40 may be angled or curved relativeto the driver 34 such that the driver 34 would contact at least onepaddle 40 if the driver 34 moved distally. At least one paddle 40 may beangled or curved toward the staple 24, such that the outer edge of thatpaddle 40 contacts an inner surface 27 of a tine 26 of the staple 24.That is, the paddle 40 may be angled, curved or otherwise shaped suchthat at least part of the paddle 40 is positioned between the tines 26of the staple 24 and is distal to at least part of the staple 24 whenthe staple 24 is in an initial position. As a result, the paddle orpaddles 40 may act both to restrain the staple 24 against distal motionand to hold the staple 24 in its initial configuration.

When the end effector 4 is in the initial position, the staple 24 isalso in an initial position. In the initial position, each ridge 41 ofeach paddle 40 may be positioned distal to a corresponding valley 29 ofthe staple 24. Further, when the end effector 4 is in the initialposition, the distal end of the driver 34 may be positioned against orin proximity the peaks 28 of the staple 24, thereby substantiallyrestraining the staple 24 against motion in the proximal direction. Thestaple 24 may be held substantially in place while the end effector 4 isin the initial position in any suitable manner. For example, the staple24 may be gently friction-fit against a portion of the housing 22.

Referring also to FIG. 1, the shaft 6 extends proximally from the endeffector 4. The shaft 6 may be flexible or rigid. The shaft 6 may bearticulated in at least one location, if desired. Referring also to FIG.7, the shaft 6 and the end effector 4 are both sized to pass through astandard sheath 48 used in a catheterization procedure. One or moreblood leakage indicators 50 may be defined in the shaft 6. At least oneblood leakage indicator 50 may be a groove or depression extending alongat least part of the length of the shaft 6, and extending distally farenough that the distal end of the blood leakage indicator 50 is distalto the distal end of the sheath 48 when the closure system 2 is in use.Optionally, the shaft 6 may include a cutaway, trough or other feature(not shown) to allow the guidewire (if any ) used in the catheterizationprocedure to remain in place during actuation of the closure system 2.Alternately, the closure system 2 may include or be configured to followa second guidewire separate from the one utilized to perform a medicalprocedure.

The handle 8 is connected to the shaft 6, such as to the proximal end ofthe shaft 6. The shaft 6 may be fabricated such that the handle 8 issimply the proximal end of the shaft 6. Alternately, the shaft 6 and thehandle 8 may be two separate items that are connected together in anysuitable manner. The handle 8 may include any mechanism, mechanisms,structure or structures configured to actuate the end effector 4. Forexample, as described later in this document, the handle 8 may beconfigured to actuate the butterfly members 10 and the driver 34. Thus,any suitable mechanism or mechanisms that are configured to actuate thebutterfly members 10 and the driver 34 may be used. A rod (not shown)may be attached to the driver 34, extending through the shaft 6 to thehandle 8. The rod may be rigid enough to transmit force distally, andmay be flexible enough to move along the shaft 6 where the shaft 6 isflexible. Alternately, a cable may be connected to the driver 34, andthat cable may be directed around an axle, nose or other feature (notshown) of the end effector 4 in order to convert proximal motion of thecable to distal motion of the driver 34. Alternately, the driver 34,and/or any other suitable component of the end effector 4, may extendthrough the shaft 6 to the handle 8, in order to be actuated directly bythe handle 8, and may connect directly to a mechanism, mechanisms,structure or structures in the handle 8 configured to actuate the endeffector 4. Alternately, a butterfly cable (not shown) may be connectedto the proximal end of each butterfly member 10. Each butterfly member10 may be connected to an individual butterfly cable, or at least twobutterfly members 10 may be connected to the same butterfly cable. Eachbutterfly cable may be connected to either element 12, 14 of at leastone corresponding butterfly member 10. Motion of the butterfly cableresults in motion of the corresponding element 12, 14.

The handle 8 may also include a source of stored energy for actuatingthe end effector 4. The source of stored energy may be mechanical (suchas a spring), electrical (such as a battery), pneumatic (such as acylinder of pressurized gas) or any other suitable source of storedenergy. The source of stored energy, its regulation, and its use inactuating the end effector 4 may be as described in the U.S. patentapplication Ser. No. 11/054,265, filed on Feb. 9, 2005, which is hereinincorporated by reference in its entirety. The handle 8 may instead, oralso, include a connector or connectors suitable for receiving storedenergy from an external source, such as a hose connected to a hospitalutility source of pressurized gas or of vacuum, or an electrical cordconnectable to a power source.

Alternately, the closure system 2 may include at least two separatecomponents: a butterfly deployment tool connected to and configured toplace the butterfly members 10, and a staple placement tool which isconnected to the end effector 4 and configured to place the staple 24.In this embodiment, the closure system 2 includes two or more separatetools, in contrast to the closure system 2 disclosed above that is asingle integrated tool. The staple placement tool may be slidablerelative to the butterfly deployment tool, or vice versa. As oneexample, at least a portion of the butterfly deployment tool may betubular, and at least a portion of the staple placement tool may beconfigured to slide within the lumen of the tubular portion of thebutterfly deployment tool. As another example, the butterfly deploymenttool and/or the staple placement tool may include a groove definedtherein, where the other tool includes a rail, rib or other structureconfigured to slide along that groove. Separating the functions ofbutterfly deployment and staple placement may facilitate the deploymentof multiple staples 24, as described in greater detail below.

Operation

Referring to FIGS. 7 and 14, in the course of a standard catheterizationprocedure, a sheath 48 is inserted through a passage 53 in tissue 52such that one end of the sheath 48 enters an opening 54 in a bloodvessel 56. The passage 53 extends between the epidermis 55 of thepatient and the opening 54 in the blood vessel 56. The sheath 48 may beadvanced any suitable distance into the blood vessel 56, as determinedby the physician performing the procedure. When the sheath 48 is inplace, at least one blood leakage indicator 50 is exposed to bloodwithin the blood vessel 56, allowing blood to flow outward therethrough.As an example of a catheterization procedure, the blood vessel 56 may bea femoral artery, and the tissue 52 may be the tissue of the leg betweenthe surface of the leg and the femoral artery. However, the blood vessel56 may be a different blood vessel, and the tissue 52 may be differenttissue in the vicinity of that different blood vessel. During thecatheterization procedure, any suitable tools are utilized to performthe desired treatment on the patient, such as the placement of one ormore stents in the coronary arteries or peripheral vessels of thepatient. After the treatment has been performed, the tools utilized toperform that treatment are removed from the patient via the sheath 48,and the sheath 48 is left in place.

Referring also to FIG. 2, the end effector 4 of the closure system 2 isinserted into the sheath 48. The end effector 4 may be advanced alongthe sheath 48 in any suitable manner. As one example, the end effector 4is manually pushed along the sheath 48 by the physician or other user byapplying a force to the shaft 6 and/or the handle 8 after the endeffector 4 has entered the sheath 48. Each butterfly member 10 initiallymay be in its first, collapsed configuration as the end effector 4 isadvanced along the sheath 48. The end effector 4 continues to advancedistally into the sheath 48 until at least the distal end 16 of at leastone butterfly member 10 is distal to the distal end of the sheath 48.That is, the end effector 4 is advanced along the sheath 48 until atleast the distal end 16 of at least one butterfly member 10 is outsideof the lumen of the sheath 48. This position of the end effector 4relative to the sheath 48 may be referred to as the standby position.The sheath 48 has a known length, and at least part of the end effector4 is advanced along the lumen of the sheath 48 a distance greater thanthe length of the sheath 48. Thus, the particular position of the distalend of the sheath 48 in the lumen of the blood vessel 56 need not beknown in order for the end effector 4 to be advanced to the standbyposition. Optionally, one or more markings may be placed on the shaft 6,such that when those one or more markings enter the lumen of the sheath48, the end effector 4 has been advanced to the standby position. Themarking or markings on the shaft 6 are placed at a distance from thedistal end of the end effector 4 that is greater than the length of thesheath 48.

Optionally, a guidewire (not shown) utilized in the catheterizationprocedure may remain in the lumen of the sheath 48, and the end effector4 and shaft 6 may follow that guidewire in any suitable manner. As oneexample, where a cutaway, groove or other feature is defined in the endeffector 4 and/or shaft 6, that feature may slide along the guidewire.Optionally, the guidewire used in the catheterization procedure isremoved from the lumen of the sheath 48 prior to the introduction of theend effector 4 into the sheath 48, and a second, thinner guidewireconfigured for use with the closure system 2 is inserted through thelumen of the sheath 48 and into the lumen of the blood vessel 56. Theoriginal guidewire may be removed before or after the placement of thesecond guidewire. The second, thinner guidewire, if used, may be moreconvenient to remove from the opening 54 in the blood vessel 56 afterthe staple 24 has been closed.

After the end effector 4 is in the standby position, at least onebutterfly member 10 is actuated to move from its first, collapsedconfiguration to its second, expanded configuration. This actuation maybe performed in any suitable manner. Referring also to FIG. 8, as oneexample, the second element 14 of each butterfly member 10 is heldsubstantially in place, and the first element 12 of each butterflymember 10 is pulled proximally in any suitable manner. As one example,the elements 12, 14 each extend through the shaft 6 to the handle 8, anda mechanism or mechanisms in the handle 8 push or otherwise move thefirst element 12 proximally. As another example, the first element 12 isconnected to a cable or other force transmission member, and the handle8 exerts a proximal force on that cable, which in turn moves the firstelement 12 proximally.

Proximal motion of the first element 12 relative to the second element14 exerts a compressive force on the segments 18, substantially in thelongitudinal direction. Because at least one segment 18 is angled,curved or otherwise offset from the longitudinal direction, thatlongitudinal force results in a moment that acts on at least part of atleast one segment 18. As a result of that moment, each segment 18rotates outward from the longitudinal centerline of the first element 12about the hinge member 20 as well as about the point of connectionbetween each segment 18 and a remainder of the first element 12. Thehinge member 20 allows the segments 18 to rotate relative to one anotherat a defined point, by providing a weakened area or other feature thatis configured to bend upon the application of a force that is less thanthe amount of force needed to bend the segments 18 themselves. Thedeflection of the segments 18 as a result of the application of momentsthereto may be plastic deformation. Alternately, that deflection may beelastic deformation. After the segments 18 of a butterfly member 10complete their deflection, that butterfly member 10 is in the second,expanded configuration. Alternately, the segments 18 are bendable,rather than deformable. Alternately, a single segment 18, rather thantwo separate segments, is provided. As another example, the firstelement 12 of each butterfly member 10 is held substantially in place,and the second element 14 of each butterfly member 10 is pusheddistally, such as by a rod or other rigid linkage attached to the end ofeach second element 14. This motion of the second element 14 relative tothe first element 12 exerts a compressive force on the segments 18,which then deform to the second, expanded configuration substantially asdescribed above.

The sheath 48 may be removed from the tissue 52 of the patient prior tothe expansion of at least one butterfly member 10. Referring also toFIG. 16, the closure system 2 may be configured such that removal of thesheath 48 from the tissue of the patient causes or allows expansion ofat least one butterfly member 10. For example, referring also to FIG.8A, the sheath 48 may include or be connected to a ring 58 or otherstructure at its proximal end. The handle 8 may include a button 60 atits distal end. The shaft 6 is positioned within the lumen of the sheath48. As the sheath 48 is slid proximally out of the tissue 52 of thepatient along the shaft 6, the ring 58 contacts the button 60, moving itfrom a first position to a second position. This motion of the button 60may actuate a mechanism or mechanisms within the handle 8 to allow atleast one butterfly member 10 to move to an expanded configurationand/or to cause at least one butterfly member 10 to move to an expandedconfiguration. Each butterfly member 10 in the expanded configuration islocated within the lumen of the blood vessel 56. Alternately, the sheath48 remains in place as at least one butterfly member 10 moves to theexpanded configuration. Alternately, the actuation of at least onebutterfly member 10 to move to the expanded configuration may becompletely independent of the position of the sheath 48 relative to thehandle 8 or any other component of the closure system 2.

Next, referring also to FIG. 17, the closure system 2 is movedproximally until the expanded butterfly member or members 10 contact theinner wall of the blood vessel 56, in proximity to the opening 54. Thebutterfly members 10 are held substantially stationary relative to thehousing 22 as the closure system 2 is moved proximally. The closuresystem 2 may be moved proximally in any suitable manner. As one example,the handle 8 is manually moved proximally, causing the expandedbutterfly member or members 10 to contact the inner wall of the bloodvessel 56. When the closure system 2 reaches the position in which asegment 18 of each expanded butterfly member 10 contacts the inner wallof the blood vessel 56, the blood leakage indicator or indicators 50have moved out of the lumen of the blood vessel 56 through the opening54, and into the passage 53 in the tissue 52. As a result, the flow ofblood through the blood leakage indicator or indicators 50 decreases orstops, indicating to the operator that the butterfly member or members10 are positioned against the inner surface of the wall of the bloodvessel 56.

Referring also to FIGS. 9 and 18, each butterfly member 10 is then movedproximally while the housing 22 is held in a substantially constantposition. The butterfly members 10 are moved such that each butterflymember 10 is maintained in an expanded configuration as it movesproximally. As a result, the expanded portion of each butterfly member10 pulls the wall of the blood vessel 56 toward the distal end of thehousing 22, capturing the wall of the blood vessel 56 and registeringthe opening 54 in the blood vessel 56 to the distal end of the housing22. The expanded portion of each butterfly member 10 may be wider thanthe opening 54 to facilitate this motion of the wall of the blood vessel56. Advantageously, the expanded portion of each butterfly member 10 maybe moved within one-half millimeter of the distal end of the housing 22.However, the distance that the expanded portion of each butterfly member10 is moved may be more or less. Alternately, at least one butterflymember 10 is moved relative to a force, rather than a distance. That is,a particular force is exerted proximally on the butterfly member 10,causing it to move proximally until the force exerted on the butterflymember 10 by the wall of the blood vessel 56 in the distal direction issubstantially equal to the force exerted on the butterfly member 10 inthe proximal direction. Thus, the wall of the blood vessel 56 is movedinto position in preparation for stapling. The wall of the blood vessel56 is held in position against the distal end of the housing bycompressive force exerted against the housing 22 by the expanded portionof each butterfly member 10. The movement of each butterfly member 10may be accomplished in any suitable manner. For example, at least oneelement 12, 14 of at least one butterfly member 10 extends to the handle8, and at least one of those elements 12, 14 is actuated directly by amechanism or mechanisms associated with the handle 8. As anotherexample, both the first and the second elements 12, 14 of at least onebutterfly member 10 may be moved proximally by a cable or cablesattached to the elements 12, 14. Alternately, the expanded portion ofeach butterfly member 10 is held substantially stationary, and thehousing 22 is advanced distally. Such motion of the housing 22 may beaccomplished in a manner similar to that described above with regard tothe motion of the butterfly members 10. For example, each butterflymember 10 may be held substantially stationary relative to the handle 8,which in turn is held substantially stationary relative to the bloodvessel 56. A force in the proximal direction is then exerted on thehousing 22, such as via a member capable of transmitting compressiveforce, where that member extends through the shaft 6 to the handle 8.

Next, referring also to FIG. 10, the driver 34 advances distally. Thedriver 34 may be actuated to advance distally in any suitable manner. Asone example, the driver 34 is urged distally when the handle 8 exerts adistal force on a member (not shown) or other structure or mechanismconnected to the driver 34. The handle 8 may exert such a force in anysuitable manner, as described above. As another example, the driver 34extends through the shaft 6 to the handle 8, and the driver 34 isactuated directly by a mechanism or mechanisms associated with thehandle 8. As another example, a cable is connected to the driver 34, andthat cable is directed around a nose, axle or other feature (not shown)of the end effector 4 distal to the driver 34 in order to convertproximal motion of the cable to distal motion of the driver 34.

As the driver 34 advances distally, the driver 34 exerts a force in thedistal direction on the staple 24. Each ridge 41 restrains thecorresponding valley 29 of the staple 24 substantially against distalmotion, such that the longitudinal position of the peaks 28 and thetrough 30 of the staple are substantially unchanged as the driver 34begins to exert a distal force on the staple 24. However, the tines 26are not substantially restrained against motion resulting fromapplication of force in the distal direction. The distal force exertedon at least one peak 28 of the staple 24 by the driver 34 urges eachvalley 29 of the staple 24 against the corresponding ridge 41 of thepaddle 40. Each ridge 41 is positioned sufficiently far from thelongitudinal centerline of the staple 24 such that a moment is generatedabout that ridge 41 that is applied to the corresponding peak 28 of thestaple 24. This moment causes the corresponding tine 26 of the staple 24to move outward from the longitudinal centerline of the staple 24. Eachridge 41 may be shaped, sized, positioned or otherwise configured in anymanner that results in such a moment and the resultant motion of thetines 26 of the staple 24.

Thus, as the driver 34 exerts a force on the staple 24, the distal endsof the tines 26 of the staple 24 move apart from one another, each in adirection away from the longitudinal centerline of the staple 24. Thisdeformation of the staple may be referred to as “splaying.” Duringsplaying of the staple 24, the tines 26 themselves may remainsubstantially undeformed; rather, a portion of the staple 24 inproximity to each peak 28 and/or the trough 30 may deform. Alternately,at least one tine 26 may deform during splaying of the staple 24.Further, as the distal ends of the tines 26 move away from thelongitudinal centerline of the staple 24, at least part of each tine 26may move outside the distal end of the housing 22 through a slot 23 orother opening in the housing 22. As a result, the tines 26 of the staple24 may move apart from one another a distance greater than the diameterof the housing 22. Where the staple 24 is made from aplastically-deformable material such as stainless steel, the staple 24deforms plastically as it splays from its initial configuration to thesplayed configuration. Plastic deformation is deformation that remainsafter the load that caused it is removed, or that would remain if theload were removed. Alternately, the staple 24 is elastically-deformablefrom its initial configuration to the splayed configuration. The staple24 may be spring-loaded inwards to the initial configuration, such thatthe staple 24 springs outward and returns to the splayed configurationupon application of force or upon movement to a position relative to thehousing 22 such that the staple 24 is free to spring outward.Alternately, the staple 24 does not deform or move to a splayedconfiguration at all; rather, it transitions directly from the initialconfiguration to a closed configuration as described below. If thestaple 24 does not deform or move to a splayed configuration, then thetines 26 may be spaced apart as far as possible within the housing 22when the staple 24 is in the initial configuration, such that the tines26 are farther apart from one another than shown in FIG. 5.

Alternately, where at least one paddle 40 is angled or curved relativeto the driver 34 as described above, as each tine 26 moves its innersurface 27 contacts an outer edge of the paddle 40. Such contact betweeneach tine 26 and the corresponding paddle 40 causes the staple 24 tosplay. That is, at least one tine 26 of the staple 24 moves away fromthe longitudinal centerline of the staple 24.

After the staple 24 has deformed to a splayed configuration, as shown inFIG. 10, the driver 34 continues to apply a force in the distaldirection on the staple 24. This force pushes the splayed staple 24 atleast partially onto each ridge 41, in turn causing the paddle 40associated with each ridge 41 to deflect away from the longitudinalcenterline of the driver 34, which at this point in the operation of theclosure system 2 is substantially coaxial with the longitudinalcenterline of the staple 24. The staple 24 then moves distal to theridge or ridges 41. As the staple 24 moves distally, the driver 34encounters each ridge 41. Contact between the driver 34 and each ridge41 holds each paddle 40 in a position deflected away from thelongitudinal centerline of the driver 34. After the staple 24 has moveddistally to the ridge or ridges 41, it may advance rapidly toward thedistal end of the housing 22, as the portion of the paddle 40 distal toeach ridge 41 is out of the path of travel of the staple 24. Further, asthe staple 24 advances, the tab 32 in the staple 24 slides along asubstantially longitudinal groove 47 defined in the finger 42. Thegroove 47 may extend completely through the finger 42, or may be adepression defined in the finger 42. The tab 32 may extend into thegroove 47 of the finger 42. Interaction between the tab 32 of the staple24 and the groove 47 may maintain the staple 24 in a desired orientationduring its splaying, shuttling forward, closing and/or ejecting.Alternately, the tab 32 and/or a different registration element of thestaple 24 rides along a corresponding registration element defined inthe housing 22. The motion of the staple 24 between its splaying and theentry of the tines 26 into tissue 56 may be referred to as “shuttling.”During shuttling, the compressive force that deformed the staple 24 intothe splayed configuration is substantially removed from the staple 24,because the staple 24 is free to move forward; the force exerted by thedriver 34 on the staple 24 moves it distally rather than furtherdeforming it.

Referring also to FIG. 7 and 10A, as the driver 34 continues to movedistally, it pushes the distal ends of the tines 26 out of the distalend of the housing 22, and the distal ends of the tines 26 thenpenetrate the wall of the blood vessel 56. The speed of the shuttling ofthe staple 24 may be controlled to facilitate penetration of the wall ofthe blood vessel 56. The staple 24 is in the splayed configuration asthe distal ends of the tines 26 penetrate the wall of the blood vessel56. The distal ends of the tines 26 are positioned further apart fromone another when the staple 24 is in the splayed configuration than whenthe staple 24 is in the initial configuration, thereby allowing captureof tissue across a width greater than that of the housing 22 between thetines 26 as they enter and penetrate tissue 56. The staple 24 in thesplayed configuration penetrates tissue 56 on opposite sides of theopening 54. The staple 24 may be positioned substantially across thecenter of the opening 54. Alternately, more than one staple 24 isdeployed to close the opening 54.

As the driver 34 continues to move distally, it continues to move thestaple 24 distally. As the staple 24 moves distally, the trough 30 ofthe staple encounters the projection 46 that extends from the finger 42.The projection 46 is positioned in the path of the staple 24 in order tocontact the trough 30 of the staple 24 as it moves distally. Thatcontact causes distal motion of the staple 24 to substantially stop.However, the driver 34 continues to exert a force in the distaldirection on the staple 24, such as on the peaks 28 of the staple 24.

After the staple 24 substantially ceases its distal motion, the driver34 continues to apply a distal force to the staple 24. Each peak 28 ofthe staple 24 is offset from the longitudinal centerline of the staple24. Further, the longitudinal centerline of the staple 24 substantiallyintersects or approaches close to intersection with the projection 46.As a result, each peak 28 of the staple 24 is offset from theprojection. The force exerted by the driver 34 distally on each peak 28of the staple 24, which is offset from the longitudinal centerline ofthe staple 24, results in a moment about the projection 46, which actsas an anvil. Each tine 26 of the staple 24 that experiences that momentmoves toward the longitudinal centerline of the staple 24. In the courseof this motion, the distal ends of the tines 26 may first move towardthe longitudinal centerline of the staple 24 and toward one another,cross each other, then move away from the longitudinal centerline of thestaple 24 and away from one another. The tines 26 need not substantiallychange shape as they move; rather, they may rotate about a pivot pointlocated at or near the trough 30. Alternately, one or both of the tines26 may deform as they move. The radius of curvature of each tine 26 maybe substantially coincident with its path of travel during closure ofthe staple 24. Deformation of the staple 24 as a result of contactbetween the staple 24 and the projection 46 may be referred to as“closing” the staple 24.

Referring also to FIG. 11, as the driver 34 continues to move distally,the staple 24 continues to deform against the projection 46. Thisdeformation may be plastic deformation from the splayed configuration toa final, closed configuration. The staple 24 and/or any other componentof the end effector 4 may be shaped or otherwise configured such thatthe tines 26 swipe past one another as the staple 24 moves to the closedconfiguration. Referring also to FIG. 12, as one example, the staple 24is shaped such that the application of force longitudinally theretocauses the tines 26 to move in a direction that has a component ofmotion perpendicular to the longitudinal direction, thereby moving thetines 26 such that they swipe past each other. The staple 24 may becurved in any manner to allow for such motion of the tines 26. Forexample, the proximal surface 62 of the staple 24 may take the shape ofa twisted plane, as described above. Contact between the driver 34 andthe proximal surface 62 of the staple thus causes the tines 26 to moveapart from one another in a direction perpendicular to the direction inwhich the legs move toward one another as the staple 24 moves to aclosed configuration, such that the tines 26 swipe past one another asthe staple 24 closes. That is, because the force applied to the proximalsurface 62 of the staple 24 is substantially in the longitudinaldirection, and the proximal surface 62 of the staple 24 is twisted suchthat lines perpendicular to that proximal surface 62 on opposite lateralsides of the staple 24 are skewed in opposite directions relative to thelongitudinal direction, the force applied to the staple 24 tilts thetines 26 in opposite directions. Thus, when the staple 24 is closed, thetines 26 may be both offset from and substantially adjacent to oneanother. Alternately, at least two tines 26 of the staple 24 areconfigured to interfere with or otherwise engage one another when thestaple 24 is in the closed position. Alternately, at least two tines 26may be substantially parallel to one another and spaced apart from oneanother when the staple 24 is in the closed position.

Alternately, the distal ends of the tines 26 of the staple 24 are shapedsubstantially conically. As the staple 24 closes, the conical tips ofthe tines 26 come into contact with one another. As a result of theangle of the side of each conical tip, this contact causes the tines 26to slide adjacent to one another instead of interfering with oneanother. Alternately, the distal end of each tine 26 is substantiallyplanar, where each plane is oriented in a different direction. As aresult, when the distal ends of the tines 26 encounter one another,contact between the differently-oriented planes at the distal ends ofthe tines pushes the tines 26 out of plane relative to one another.Alternately, the tines 26 of the staple 24 are fabricated such that theyare out of plane with one another when the staple 24 is in the initialconfiguration, such that the tines 26 do not substantially interferewith one another during deployment. Alternately, the tines 26 of thestaple 24 are plastically deformed out of plane with one another bycontact with the paddle 40 while the staple 24 is splayed open and/orbeing closed. Alternately, the staple 24 and/or the end effector 4 areconfigured to prevent the tines 26 from interfering with one another asthe staple 24 closes.

When deformation of the tines 26 of the staple is complete, the staple24 is in the closed configuration. In that closed configuration, atleast part of each tine 26 of the staple is located within the lumen ofthe blood vessel 56. The tines 26 may be positioned such that a part ofeach tine 26 is positioned against an inner surface of the blood vessel56. Alternately, the tines 26 may be positioned differently relative tothe wall of the blood vessel 56. In the closed configuration, the staple24 holds opposite sides of the opening 54 together, substantiallyclosing the opening 54. Where the staple 24 is frangibly connected tothe driver 34, force is exerted on the staple 24 when the staple 24approaches or reaches the closed configuration, in order to separate thestaple 24 from the driver 34 such as by fracturing. The force on thestaple 24 may be provided in any suitable manner. As one example, theconnection between the staple 24 and the driver 34 may be shaped andsized such that the forces exerted on the staple 24 to deform it to theclosed configuration also cause the staple 24 to separate from,thedriver 34. Alternately, the staple 24 is not separated from the driver34 until the staple 24 is ejected from the housing 22. Alternately, thestaple 24 is separated from the driver 34 at any other suitable timeduring the deployment process.

In the course of deflecting the staple 24 to the closed configuration,the driver 34 moves to a distalmost position. The distalmost position ofthe driver 34 may be controlled in any suitable manner. As one example,the distalmost position of the driver 34 is controlled by the handle 8.As another example, contact between the distal end of the driver 34 andat least one post 43 extending from a corresponding paddle 40 preventsthe driver 34 from moving further in the distal direction, therebydefining the distalmost position of the driver 34.

After the staple 24 has been closed, the driver 34 is moved proximally.As the driver 34 moves proximally, it continues to engage at least oneridge 41 extending from each paddle 40, such that the paddles 40continue to be deflected away from their original, rest position. As thedriver 34 continues to move proximally, the distal end of the driver 34moves over and then proximal to each ridge 41. After the distal end ofthe driver 34 has moved proximal to each ridge 41, the driver 34 nolonger pushes the corresponding paddle 40 from its original position.Consequently, each paddle 40 moves back toward its original position.Advantageously, the deflection of each paddle 40 away from its originalposition is substantially elastic, such that in the deflected positioneach paddle 40 is biased toward its initial position. Alternately, atleast one paddle 40 is plastically deformed away from its originalposition as the driver 34 moves distally, and each such paddle 40 doesnot return to its original position when the distal end of the driver 34moves proximal to the corresponding ridge 41. If so, when the driver 34retracts proximally, a feature on the driver 34 and/or a separate member(not shown) plastically deform the paddle 40 back toward its initialposition in order to eject the staple, as described below. Alternately,at least one paddle 40 is not deflectable from a cantilevered base, butinstead is movable relative to the housing 22 in any suitable direction.

As each paddle 40 moves back toward its original position, it exerts aforce on the closed staple 24 along the projection 46, urging the staple24 along the projection 46 away from the finger 42 and toward the freeend of the projection 46. When each paddle 40 moves close to orcompletely into its initial position, it has moved far enough to pushthe closed staple 24 off the free end of the projection 46. The closedstaple 24 is then free to exit the housing 22 of the end effector 4.

Next, each butterfly member 10 is deformed from the expandedconfiguration back to the collapsed configuration. This deformation maybe performed by reversing the steps described above for deforming thebutterfly member 10 from the collapsed configuration to the expandedconfiguration. Where at least one butterfly member 10 elasticallydeformed from the collapsed configuration to the expanded configuration,force exerted on that butterfly member 10 to maintain the butterflymember in the expanded configuration is simply released, allowing thebutterfly member 10 to return to the collapsed configuration.

After each butterfly member 10 returns to the collapsed position, theend effector 4 is moved proximally, and the butterfly members 10 thenexit from the opening 54. Advantageously, where two butterfly members 10are used, one butterfly member 10 is located on each side of the closedstaple 24. As the end effector 4 is moved away from the opening 54, thestaple 24 exits the distal end of the housing 22, as it grasps thetissue 56 with greater force than any remaining frictional forces orother incidental forces holding it to the housing 22. The guidewire, ifused, is then removed from the blood vessel 56. Alternately, theguidewire is removed at a different time. The guidewire is pulled out ofthe blood vessel 56 adjacent to the closed, staple 24 and between theedges of what had been the opening 54 in the blood vessel 56. Thus, asmaller-diameter guidewire may be advantageous, as it may leave asmaller gap in tissue between the edges of what had been the opening 54in the blood vessel, such that the wall of the blood vessel can reboundmore quickly to close that gap. After the end effector 4 is removed fromthe patient, the sheath 48 is removed if it is still present in thepatient. The procedure is complete, and the opening 54 is substantiallyclosed.

Where the closure system 2 includes a separate butterfly deployment toolconnected to and configured to place the butterfly members 10, and aseparate staple placement tool which is connected to the end effector 4and configured to place the staple 24, each of the two separatecomponents is substantially as described above with regard to thesingle, integrated tool, with minor variations. First, the butterflydeployment tool is inserted through the opening 54 in the blood vessel56 and actuated such that a part of each butterfly member 10 is in theexpanded configuration and seated against the inner surface of the wallof the blood vessel 56. Then, the staple placement tool is slid alongthe butterfly, deployment tool toward the opening 54 in any suitablemanner, and actuated substantially as described above. The stapleplacement tool is then withdrawn. Optionally, a second staple placementtool then may be advanced toward the opening 56 and actuated. The secondstaple placement tool may be used in the event that the first stapleplacement tool did not close the opening 56 to the satisfaction of thephysician, in order to place a second staple for additional security, orfor any other reason. After the staple placement tool is withdrawn, thebutterfly deployment tool is withdrawn, the opening 56 is substantiallyclosed, and the procedure is complete.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. It is to be understood that the invention is not limited tothe details of construction, the arrangements of components and/or thedetails of operation set forth in the above description or illustratedin the drawings. Headings and subheadings are for the convenience of thereader only. They should not and cannot be construed to have anysubstantive significance, meaning or interpretation, and should not andcannot be deemed to be limiting in any way, or indicate that all of theinformation relating to any particular topic is to be found under orlimited to any particular heading or subheading. The contents of eachsection of this document are merely exemplary and do not limit the scopeof the invention or the interpretation of the claims. Therefore, theinvention is not to be restricted or limited except in accordance withthe following claims and their legal equivalents.

1. A system for closing an opening in tissue, comprising: an endeffector having a longitudinal axis, said end effector including atleast one paddle; and a staple having a plurality of tines, wherein saidstaple is held by said end effector and wherein at least part of atleast one said paddle is movable relative to said staple.
 2. The systemof claim 1, wherein said paddle is deflectable away from saidlongitudinal axis.
 3. The system of claim 1, wherein said staple isplastically deformable.
 4. The system of claim 1, wherein at least onesaid tine has a substantially conical tip.
 5. The system of claim 1,wherein said staple has two said tines.
 6. The system of claim 1,further comprising a base from which each said paddle is cantilevered,wherein said paddle extends distally from said base.
 7. The system ofclaim 1, further comprising a driver positioned proximal to said staple,wherein said driver is configured for engagement with said staple and atleast one said paddle.
 8. The system of claim 7, wherein said engagementbetween said driver and at least one said paddle deflects said paddleaway from said longitudinal axis.
 9. The system of claim 1, furthercomprising a finger extending substantially longitudinally andsubstantially adjacent to at least one said paddle, wherein said fingerincludes a projection, and wherein said staple is movable into contactwith said projection.
 10. The system of claim 9, wherein said fingerincludes a groove defined therein.
 11. The system of claim 10, whereinsaid staple includes at least one tab extending therefrom leastpartially away from at least one said tine, and wherein said tab engagessaid groove.
 12. The system of claim 9, wherein said paddle isdeflectable away from said finger from an original position, and whereinsaid paddle is movable back toward its original position to push saidstaple along said projection.
 13. The system of claim 1, wherein saidend effector includes a housing and at least one butterfly memberextending distally from said housing, wherein at least one saidbutterfly member is movable between a collapsed configuration and anexpanded configuration.
 14. The system of claim 13, wherein at least onesaid butterfly member is movable relative to said housing.
 15. Thesystem of claim 1, further comprising a shaft connected to said endeffector.
 16. The system of claim 15, further comprising a handleconnected to said shaft.
 17. The system of claim 1, wherein said stapleis initially positioned at a location spaced apart from the distal endof said end effector.
 18. A tool for closing an opening in tissue,comprising: a staple including a plurality of tines, said stapleplastically-deformable to a splayed configuration and a closedconfiguration; and an end effector including a driver, wherein saiddriver is movable to exert a force in the distal direction on a proximalsurface of said staple to splay said staple to said splayedconfiguration and close said staple to said closed configuration. 19.The tool of claim 18, wherein said staple is a substantially continuoussolid.
 20. The tool of claim 18, wherein said staple is plasticallydeformable to said splayed configuration and to said closedconfiguration.
 21. The tool of claim 18, wherein at least one saidpaddle includes a ridge extending therefrom, wherein each said ridge isspaced from the longitudinal centerline of the staple a sufficientdistance such that contact between said driver and said staple generatesa moment about said ridge that deforms said staple to said splayedconfiguration.
 22. The tool of claim 18, wherein the distal end of saiddriver is bifurcated.
 23. A method for closing an opening in tissue,comprising: providing a staple having a plurality of tines and alongitudinal centerline, wherein said staple is a substantiallycontinuous solid; plastically deforming said staple to a splayedconfiguration; penetrating at least one said tine into tissue inproximity to the opening; and plastically deforming said staple to aclosed configuration.
 24. The method of claim 23, wherein saidplastically deforming at least one said tine toward said longitudinalcenterline includes deforming at least one said tine to a positionoffset from and substantially adjacent to another said tine.
 25. Themethod of claim 23, further comprising providing a housing; and holdingsaid staple at least partially within said housing.
 26. The method ofclaim 25, wherein said holding comprises holding said staple at alocation spaced apart from the distal end of said housing.
 27. Themethod of claim 25, wherein said holding comprises holding said staplecompletely within said housing at a location spaced apart from thedistal end of said housing before said plastically deforming said stapleto a splayed configuration.
 28. The method of claim 25, furthercomprising registering the opening in tissue to said housing.
 29. Themethod of claim 28, wherein said registering includes maintaining saidhousing substantially stationary; and moving the tissue toward saidhousing.
 30. The method of claim 28, wherein said registering includes:providing at least one butterfly member extending substantially distallyfrom said housing; inserting at least part of at least one saidbutterfly member into the opening in a collapsed configuration;expanding at least part of at least one said butterfly member to anexpanded configuration; and moving at least one of said butterfly memberin said expanded configuration and said housing toward the other. 31.The method of claim 30, further comprising: collapsing each saidbutterfly member in said expanded configuration to said collapsedconfiguration; and withdrawing each said butterfly member from theopening.
 32. The method of claim 23, further comprising pushing saidstaple in a direction angled relative to said longitudinal centerlineafter said plastically deforming said staple to a closed configuration,whereby said pushing releases said staple.
 33. The method of claim 32,wherein said direction is substantially perpendicular to saidlongitudinal centerline.
 34. A tool for closing an opening in tissue,comprising: a housing; a staple held by said housing; and at least onebutterfly member extending distally from said housing, each saidbutterfly member including a first element and a second elementconnected to one another at the distal ends thereof; wherein at leastone said element transmits both compressive and tensile force; andwherein at least one said butterfly member is movable between acollapsed configuration and an expanded configuration.
 35. The tool ofclaim 34, wherein said second element includes two substantially planarsegments longitudinally spaced from one another and connected to oneanother by a hinge element therebetween.
 36. The tool of claim 35,wherein said segments are angled relative to one another in at least oneof said collapsed configuration and said expanded configuration.
 37. Thetool of claim 34, wherein one said element includes a lumen definedtherein into which the other said element is received.
 38. The tool ofclaim 34, wherein at least one said butterfly member is plasticallydeformable between said collapsed configuration and said expandedconfiguration.
 39. The tool of claim 34, wherein at least one saidbutterfly member is movable relative to said housing when said butterflymember is in said expanded configuration.
 40. The tool of claim 34,wherein at least one said butterfly member extends through said housingand proximal to said housing.
 41. A method for closing an opening intissue, comprising: providing a staple having a plurality of tines;plastically deforming said staple to a splayed configuration, whereinsaid deforming results from application of force in the distal directionagainst a proximal surface of said staple; penetrating at least one saidtine into tissue in proximity to the opening; and plastically deformingsaid staple from said splayed configuration to a closed configuration,wherein said deforming results from application of force in the distaldirection against a proximal surface of said staple.
 42. The method ofclaim 41, wherein said plastically deforming said staple to a splayedconfiguration includes moving an outer surface of said staple intocontact with at least one ridge, wherein said contact generates a momentabout said ridge that results in motion of said tines.
 42. The method ofclaim 41, wherein said plastically deforming said staple to said closedconfiguration includes moving an outer surface of said staple intocontact with a projection oriented at a angle to the direction of saidmoving, said contact restraining said staple against distal motion. 43.The method of claim 42, further comprising urging said staple in saidclosed configuration along and off of said projection.